The MDL court in West Virginia in the pelvic mesh litigation is continuing to issue pre-trial opinions. Amongst those issued last week was an opinion addressing 24 motions in limine filed by plaintiffs and defendant, Boston Scientific Corporation (“BSC”). Eghnayem v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 153284 (S.D.W. Va. Oct. 28, 2014). We won’t address all the court’s rulings. A number of them, as is almost always the case, were denied without prejudice to re-raising them at trial. But some are either interesting or address issues frequently raised in mass tort trials. So we discuss them here.
Exclusion of Material Safety Data Sheets (“MSDS”). Admissibility of MSDS is often an issue in drug and device law litigation. BSC sought to exclude the MSDS for polyethylene because it was not used in BSC’s mesh product. They won – for obvious reasons. The loophole that plaintiffs apparently tried to exploit was that certain BSC employees answered questions at their depositions about the polyethylene MSDS, incorrectly believing that it was the MSDS for a different substance – polypropylene – that is contained in BSC’s mesh product. The court figured that out and excluded the polyethylene MSDS.
BSC also tried to exclude the MSDS for polypropylene, a material that is in its product. No luck. BSC argued that a representative from the chemical company that made the polypropylene testified that the MSDS cautionary language was not placed there for scientific concerns. The court found that testimony to be unclear and that the witness had actually testified that he didn’t know who drafted the MSDS or why it was written. The court denied BSC’s motion, so BSC went one for two on its attempts to exclude the MSDS. Id. at *5-8.
Exclusion of Evidence that BSC Stopped Selling Its Pinnacle Product. BSC argued that this was not a recall. It was a business decision to stop selling the product. The court didn’t reach that issue, as it excluded the evidence on a different, and possibly better, ground. Since the decision to stop selling the Pinnacle product had the potential to be viewed as a subsequent remedial measure, evidence concerning that decision was excluded. Id. at *11.
Exclusion of Foreign Regulatory Actions. This issue arises in many drug or device trials, and in every litigation in which at least one foreign regulator has taken a negative action related to a device. The argument to exclude such evidence is, in essence, that we are not in those countries. We operate under a different regulatory regime, with different regulations and standards to approve devices and drugs, and often very different systems for delivering medical care. Allowing evidence of actions by selected foreign agencies would only confuse things and create a side-show of evidence on foreign regulators and why they act the way that they do. The court recognized this: “At trial, the evidence may be inadmissible because different countries have different regulatory systems and schemes.” Id. at*13. The plaintiffs argued, however, that they would use the evidence only to illustrate medical complications associated with the device. So the court punted, holding that it will address the issue in context at trial. Id. at *13-14. BSC should win this at trial too. But plaintiffs will no doubt try very hard to get this evidence in.
Exclusion of Evidence Regarding a Duty to Warn Plaintiffs Directly. The court is in West Virginia, the only state that does not recognize the learned intermediary doctrine. But this particular case is being decided under Florida law, which does recognize the doctrine. And so the court granted the motion to exclude this evidence. Id. at *15-17. While there’s nothing particularly groundbreaking about such a decision, it’s enjoyable to see it coming from a West
Exclusion of Evidence of Complications Not Experienced by Plaintiffs. This is another issue that often arises in drug and device trials. You’ll certainly face testimony concerning other complications at depositions, as doctors are often questioned on how they accounted for possible complications that have nothing to do with what the plaintiff suffered and is suing about. This court properly excluded this evidence, holding that “only the injuries experienced by the complainant are relevant.” Id. at *21.
Exclusion of Evidence Concerning Unrelated FDA Actions as to the Defendant. There apparently was a corporate warning and 483 letters from the FDA involving the defendant but not its mesh product. For obvious reasons, the court excluded it. In fact, plaintiffs conceded that they would not try to introduce such evidence given the court’s previous rulings on this issue in similar cases. Id. at *24-25.
Exclusion of Evidence That the Mesh System Is the Standard of Care. Apparently some of the treating physicians called the implantation of the Pinnacle system as the “standard of care” because plaintiffs moved to exclude such testimony from the trial. Their argument was that the only relevant standard of care was what the manufacturer should have done when deciding whether to market the product. The court disagreed. It held that evidence that the Pinnacle system was the standard of care for physicians “goes to the very essence of whether the Pinnacle is unreasonable dangerous or whether there exists a safer alternative design.” Id. at *31-32. The court denied plaintiffs’ motion.
The court is continuing to issue other pretrial rulings, and we’ll continue to report on any that may be of particular interest to you.